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510(k) K131542

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC by Novabay Pharmaceuticals, Inc. — Product Code FRO

K131542 is an FDA 510(k) premarket notification submitted by Novabay Pharmaceuticals, Inc. for the device "NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC". The FDA issued a decision of Substantially Equivalent on July 24, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Novabay Pharmaceuticals, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2013
Date Received
May 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Novabay Pharmaceuticals, Inc.

  • K143351 — iCase Contact Lens Case (April 29, 2015)
  • K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (August 8, 2012)
  • K081009 — NEUTROPHASE (May 20, 2008)
  • K071056 — NEUTROPHASE WOUND CLEANSER (September 28, 2007)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources